Phase 2
N=20
"Follow the Sutures". A New Procedure for Injection of Botulinum Toxin for Chronic Migraine
Migraine Disorders · Chronic Disease
Bottom Line
View on ClinicalTrials.gov: NCT03543254 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Number of Adverse Events — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BoNT-A (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Norwegian University of Science and Technology
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
1 | — |
| SECONDARY Injection Time |
5.47 | — |
Summary
There is no doubt that chronic migraine is a large public health problem, which is both disabling and costly. Many patients and headache doctors see Botulinum toxin (Botox) treatment as a big stride forward, but it is a problem that the effect has been shown in only one study, with a low therapeutic gain. For this reason, before this costly treatment is expanded to potentially several thousand patients in Norway, it would be highly desirable that 1) there is additional good scientific evidence for use of Botox , 2) a more effective treatment procedure is developed, 3) the potential for unblinding is reduced, and 4) the dose, number of injection sites and cost can be halved, and 5) the adverse effects are minimized. These may be the results of this pilot project where injections are given along the sutures, which can open up for a later randomized, blinded and controlled study.
Eligibility Criteria
Inclusion Criteria
- Chronic migraine, as defined in the ICHD-3 beta version
- Chronic migraine should have been present for at least ½ year prior to evaluation for study inclusion
- For women of child-bearing potential there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations
Exclusion Criteria
- Diseases that are contraindications for use of Botulinum toxin A (Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, other diseases interfering with neuromuscular function)
- Allergy to Botulinum toxin A
- Other primary or secondary headache disorder, including medication overuse headache (MOH). This means that at least one attempt to withdraw acute medication should have been performed earlier, but without success
- Severe depression or other psychiatric disorder that may interfere with the treatment
- Abuse of alcohol or illicit drugs
- Use of more than one headache prophylactic medication, or change in type and dose of prophylactic medication 10 days per month within the preceding 3 months
- Participating in another trial that might affect the current study
- Should not participate in the opinion of the investigator (e.g. not able to comply with study procedures).
Data sourced from ClinicalTrials.gov (NCT03543254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.